Olympus Revises Duodenoscope Cleaning Procedure

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Olympus sent letters to health care facilities with updated reprocessing instructions for their TJF-Q180V duodenoscope following months of media attention concerning the risk of CRE superbug infections from contaminated scopes.

The key changes are detailed in a safety communication on the FDA website for gastroenterologists, gastrointestinal surgeons, endoscopy nurses, infection control practitioners, risk managers and staff in endoscopy reprocessing units.

The FDA recommends that facilities begin using portions of the new procedure immediately. The new manual cleaning procedure involves the use of a smaller bristle cleaning brush that has not been shipped yet by Olympus. The company anticipates shipping it by early May.

In the meantime, the procedure calls for raising and lowering the elevator three times during immersion while pre cleaning, additional raising and lowering of the forceps elevator during high level disinfection, and increased flushing volume and manual flushing steps of each endoscope channel as well as the elevator recess area.

The letter from Olympus America with the Urgent Safety Notification and Updated Label Information provides their complete revised instructions. It is available at http://medical.olympusamerica.com/sites/default/files/pdf/150326_TJF-Q180V_Customer_letter.pdf

The instruction manual for the medical device previously indicated that no reprocessing of the sealed elevator wire channel was necessary.  Olympus changed the device back in 2010 but did not seek 510(k) clearance for the change.  In 2014, the FDA requested the manufacturer submit an application demonstrating the substantial equivalence of the device to prior versions.  The application is still pending.

Our attorneys have filed the first lawsuit in Philadelphia for an infection following a procedure using a duodenoscope.  The procedure took place at a Seattle hospital who has denied evidence of any CRE infections.  A Philadelphia hospital has announced a CRE superbug outbreak of at least 8 cases, including two deaths, in patients who had duodenoscope procedures in 2013 and 2014.  However, Thomas Jefferson University hospital denies that there is any link to medical scopes.  Hospitals in Seattle, Los Angeles and Pittsburgh have all had outbreaks and concluded that the CRE infections were spread by contaminated duodenoscopes.

If you are a patient who has had an ERCP procedure involving a duodenoscope, our free ebook and additional information is available at https://www.mceldrewyoung.com/superbug-infections/

Pittsburgh’s Allegheny General Hospital Latest Superbug Infection

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A Pittsburgh resident has reportedly contracted a superbug at Allegheny General Hospital following exposure to a contaminated Olympus duodenoscope, according to her lawsuit filed in Allegheny County Court of Common Pleas yesterday.

It is the third hospital to have a potential CRE infection outbreak caused by contaminated endoscopes. University of Pittsburgh Medical Center’s Presbyterian Hospital previously announced an infection outbreak linked to its use of scope in ERCP procedures. Jefferson Hospital here in Philadelphia has announced an outbreak but denied that testing warranted a conclusion that their use of duodenoscopes were linked to the spread of hospital acquired infections.

The article in the Pittsburgh Tribune-Review that I saw did not have a comment from the North Side hospital. That means that we have no idea yet if this is an isolated incident or if there are additional infections.  We also don’t know how many procedures it performs a year.

This lawsuit in and of itself will be interesting in part because it will be a unique case. The procedure took place after the FDA warned about the dangers of the medical device but before the manufacturer issued updated instructions for cleaning the scopes.

If you are interested in additional information, please visit our page dedicated to the CRE superbug infections.  We offer a free 20+ page ebook written by one our personal injury attorney for download.

Photo Credit.

Did Olympus Instruct Europe to Clean Duodenscopes with the MAJ-1888 Brush Two Years Before the United States?

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We recently acquired a document that makes us believe that Olympus told Europe to clean contaminated duodenoscopes with the smaller MAJ-1888 brush two years before it told U.S. healthcare professionals. If it did so, it put millions of individuals undergoing ERCP procedures in the United States at risk of CRE superbug infections.

The document, which is in the form of a Dear Customer letter and appears to have been created and distributed by Olympus Europe located in Hamburg, Germany, is dated January 2013.  It recognizes that there has been a reported case of contamination and advises Olympus’ customers to use the MAJ-1888 brush in cases of heavy soiling or delayed reprocessing.  The brush “enables deeper access to the forceps elevator.”  This is one of the areas that requires particular attention while reprocessing, according to the bullet points in the first paragraph of the document.

In the United States, Olympus issued new reprocessing instructions for the TJF-Q180V model on March 26, 2015. The instructions call for additional brushing of the forceps elevator recess area with the MAJ-1888 brush.  It said “Olympus anticipates shipping the MAJ-1888 brushes to facilities no later than May 8, 2015.”  It makes no mention of the fact that it told European customers to use the brush over two years.

Over the past two years, there have been a significant number of incidents at hospitals involving contaminated duodenoscopes spreading CRE superbug infections including Ronald Reagan UCLA Medical Center, Virginia Mason Medical Center in Seattle and UPMC Presbyterian in Pittsburgh. We have already filed one lawsuit here in Philadelphia against Olympus on behalf of a patient that was diagnosed with a severe infection following a duodenoscope procedure.

The document from Olympus Europe is below:

 

We’ve Filed The First Duodenoscope Lawsuit Against Olympus in Philadelphia

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Last week, McEldrew Young Purtell Merritt attorneys filed the first lawsuit in Philadelphia for a patient with a life-threatening bacteria infection following a procedure where the doctors used an Olympus TJF-Q180V duodenoscope.  The treatment took place at Harborview in Seattle, Washington.

The sealed elevator wire channel in the specialized endoscope is believed to have resulted in CRE superbug infections in patients around the country.  There have been announcements of infections linked to the device in Seattle, Los Angeles and Pittsburgh.  Patients died in both Seattle and Los Angeles – the infections have a mortality rate as high as 50 percent due to their antibiotic resistance.

Jefferson Hospital in Philadelphia had several patients diagnosed with CRE infections, and two deaths, following ERCP procedures with duodenoscopes.  The hospital denied a link between the spread of the infection and its medical devices.   We previously wrote about the Jefferson announcement here and then later commented on it.

The Law360 article covering the lawsuit is available at http://www.law360.com/articles/634196/olympus-america-hit-with-superbug-exposure-suit

For additional information and our free ebook, please visit our page on superbug infections.  For a free consultation with an attorney, please call Jim McEldrew or Dan Purtell at 1 (800) 223-3352.

 

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Duodenoscope News: Olympus Pays $6.6 Million; Fujifilm Recalls ED-530XT

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There have been two recent developments regarding the spread of CRE Superbugs via duodenoscopes used in ERCP procedures that the FDA warned about in February 2016.

Philadelphia’s Jefferson Hospital Discloses CRE Superbug Outbreak

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Thomas Jefferson University Hospital is the “unnamed hospital” with the superbug outbreak previously disclosed by the Philadelphia Department of Public Health.

Jefferson Hospital disclosed its identity today. It declared that there was “no definitive link” between duodenoscopes and the superbugs, according to the Philadelphia Inquirer article.

The superbug outbreak occurred at the hospital in Philadelphia between 2013 and 2014. There are at least eight confirmed cases with two resulting in deaths. Because duodenoscopes are usually reused on subsequent patients, dozens, if not hundreds, of local patients may have been exposed.

CRE is a very serious infection. Early symptoms of CRE infection include fever and chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting and black or tarry stools. Patients with CRE infections can suffer sepsis, blood infections, the failure or loss of organs, and even death. CRE has a mortality rate as high as 40-50%. If you believe you may have contracted the dangerous bacteria, seek medical assistance immediately.

Despite Jefferson Hospital’s somewhat suspect denial of any link between the duodenoscopes and the outbreak, other hospitals have concluded that contaminated dudodenoscopes have been to blame for CRE superbug outbreaks at their facilities.

In 2012, the University of Pittsburgh Medical Center had a superbug outbreak. Following an investigation, officials from the hospital pointed to inadequate reprocessing of duodenoscopes between patients. It found that the sealed elevator channel on the devices was harboring the deadly bacteria and they were not adequately disinfected by the standard procedure for cleaning.

More recently, the disclosure of two deaths at an an LA hospital turned the public’s attention to the problem. The disclosure of the exposure of nearly 200 patients at UCLA Ronald Reagan Medical Center in Los Angeles sparked a media frenzy surrounding the medical devices.

A duodenoscope is a flexible, lighted tube that is threaded down the throat, through the stomach and into the small intestine of the patient. It is used in 500,000 procedures annually to help doctors diagnose medical problems. There are three manufacturers of duodenoscopes: Olympus, Pentax and Fujifilm.

For more information regarding CRE infection, contact Dan Purtell at 1-800-590-4116.

Senate Investigation Identifies 25 Duodenoscope Infection Outbreaks

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Scientist using a microscope in a laboratory

The Senate investigation released today (Jan 13, 2016) indicates at least 141 patients were infected during a three year delay in reporting of the dangers of duodenoscopes, a medical scope used in ERCP procedures. The investigation identified 25 outbreaks across the country, which was “far more” than previously reported according to the Los Angeles Times coverage. Across the world, at least 250 people were infected with life-threatening illnesses, including the CRE superbug, after medical procedures with duodenoscopes. The CRE superbug is resistant to most antibiotics and has a high mortality rate (approximately half die from it).

Watch for Medical Malpractice Among Health Tech Hazards in 2016

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Over the past few years, our personal injury lawyers have been representing more clients in cases of defective or improperly used medical devices. Although part of this may be due to an expansion of our interests in this area, health technology is a growing part of the practice of medicine and this no doubt has something to do with the fact that we are seeing more defective products in potential medical malpractice cases.

CRE Superbug Disclosure at Jefferson Hospital in Philadelphia Raises Questions

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Thomas Jefferson University Hospital’s release of information concerning the superbug infection last year in Philadelphia left us speculating about whether their conclusion, “no definitive link” between duodenoscopes and the outbreak, was warranted. The Friday the 13th release about last year’s events was short on details and seemed more like the hospital intended to bury the story in the Friday evening news.  We were hoping we would get more details later but so far, we’ve heard nothing new.

Jefferson Hospital admitted to CRE infections in at least eight patients following the use of duodenoscopes from January 1, 2013 to June 1, 2014. After examining the information released, Dan Purtell, one of our trial attorneys, noted a few specific questions that he thought the hospital should have also answered:

Patient Safety
Jefferson did not release the number of patients who may have been infected by the devices or the number of ERCP procedures conducted between January 1, 2013 and June 1, 2014.

Patient Disclosures
Jefferson did not state if and how many patients were contacted by officials to disclose the potential exposure and whether these individuals were subsequently tested.

Testing
Jefferson did not identify the specific types of CRE superbug infections at issue, the testing protocol that was used, when the tests occurred or if the internal elements of the devices were specifically tested.

These are just a few of the questions that Dan identified, but they make sense.

Why Are We Asking These Questions?

Last month, the Philadelphia Department of Public Health said that two patient died with superbug infections following duodenoscope procedures in the city but that the deaths were “not clearly related” to their infections. The hospital’s silence following this disclosure was troubling.

Now, the hospital has essentially asked us to trust it that there was no link between the infections and the duodenoscopes. We would be very interested in seeing the data that supports this conclusion. After an investigation lasting several months and in light of the the high level of scrutiny of the devices, we think additional information is warranted.

In the Los Angeles outbreak at UCLA, the hospital had 170 patients potentially exposed. It notified everyone out of an abundance of caution and offered the patients free at-home testing kits. Did Jefferson do the same thing?

We would like to know.

If you have additional information about the outbreak at Jefferson, please contact Dan Purtell, Esq. at 1-800-590-4116.

If you are looking for additional information about the superbug infections, Dan has written an ebook for individuals and families that may answer some of their questions. The ebook can be downloaded at https://www.mceldrewyoung.com/superbug-infections/

President Obama Prioritizes Antibiotic Resistance After CRE Infections

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Spurred by the CRE superbug infections linked to contaminated duodenoscopes, the White House announced a five year plan to fight antibiotic resistance in a 60-page report released today on the White House blog.

The Obama plan calls for an increase in the government’s budget in this area to $1.2 billion to be used on investments in antibiotics, new diagnostic tools and better use of antibiotic drugs. The plan will also involve greater surveillance of prescribing practices and collaboration internationally with organizations such as the World Health Organization and foreign countries.

The report hopes the plan will lead to two antibiotic drugs that can be used on difficult to treat bacteria. Because of the rise of antibiotic resistance, the current pharmaceutical of last resort has been moving back to a toxic drug developed in the 1950s and prescribers stopped using in the 1970s.

The plan also reportedly calls for infection control programs related to the cleaning of hospital equipment and hand washing. Medicare and Medicaid doctors will be required to report antibiotic prescriptions to the federal government.

The goal is to reduce carbapenam-resistant Enterobacteriaceae (CRE) infections by 60 percent. The CRE infections were central. The plan also seeks to cut C. difficile and MRSA infections by at least 50 percent.

According to the U.S. Centers for Disease Control and Prevention, 2 million people are infected each year with antibiotic resistant bacteria.

The increased scrutiny of infection control procedures and antibiotic drugs can be linked to the recent outbreak of superbug infections reportedly from contaminated duodenoscopes. Over the past few years, hospitals in Philadelphia, Pittsburgh, Seattle and Los Angeles, to name a few, have had outbreaks. UPMC Presbyterian in Pittsburgh, Virginia Mason in Seattle and Ronald Reagan UCLA Medical Center in Los Angeles have linked the spread of the deadly infections to duodenoscopes.

Olympus is the largest manufacturer of duodenoscopes in the US. It made a change to its device in 2010 without seeking the FDA’s 510(K) clearance that has still not been granted clearance by the FDA. The company advised doctors and other medical professionals in a letter yesterday that they should immediately begin new cleaning procedures for the device.

For our free ebook covering the spread of CRE infections by contaminated duodenoscopes and other related information, visit https://www.mceldrewyoung.com/superbug-infections/

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